WATCHMAN™ Access Systems
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
WATCHMAN™ TruSeal™ Access System |
Not applicable. |
M635TU70020 |
WATCHMAN™ TruSeal™ Access System |
Not applicable. |
M635TU70010 |
WATCHMAN™ TruSeal™ Access System |
Not applicable. |
M635TU70040 |
WATCHMAN FXD Curve™ Access System |
Not applicable. |
M635TU80020 |
WATCHMAN FXD Curve™ Access System |
Not applicable. |
M635TU80010 |
WATCHMAN TruSteer™ Access System |
Not applicable. |
M635TU90050 |
Issue
Boston Scientific is initiating an advisory to inform customers on the important information related to the risk of air embolism during WATCHMAN™ procedures. Product is not being recalled.
Recall start date: July 29, 2025
Additional information
Details
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Get notified
Receive emails about new and updated recall and safety alerts.